MedPath

Amisulpride

Generic Name
Amisulpride
Brand Names
Barhemsys
Drug Type
Small Molecule
Chemical Formula
C17H27N3O4S
CAS Number
71675-85-9
Unique Ingredient Identifier
8110R61I4U
Background

Amisulpride is a benzamide derivative and a dopamine receptor antagonist that selectively works on dopamine D2 and D3 receptors. As an antipsychotic agent, amisulpride alleviates both positive and negative symptoms of schizophrenia, and it exhibits antidepressant properties in patients with psychiatric disorders, dysthymia, and major depression. Amisulpride predominantly works in the limbic system, which explains its relatively lower risk of extrapyramidal adverse effects compared to other atypical antipsychotic agents. Oral tablets of amisulpride is used in European countries as a treatment for acute and chronic schizophrenic disorders, as well as secondary negative symptoms in mental health disorders such as affective disorders, depressive mood, and mental retardation.

Amisulpride is also used as an antiemetic agent. In the US, the intravenous formulation of amisulpride is used to treat and prevent postoperative nausea and vomiting in adults, either as monotherapy or in combination with another antiemetic agent of a different drug class. It is marketed under the brand name Barhemsys.

Indication

Intravenous amisulpride is indicated in adults for the prevention of postoperative nausea and vomiting, either alone or in combination with an antiemetic of a different class. It is also indicated for the treatment of postoperative nausea and vomiting in patients who have received anti-emetic prophylaxis with an agent of a different class or have not received prophylaxis.

Oral amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, characterized by positive symptoms with delusions, hallucinations, thought disorders, hostility and suspicious behavior; or primarily negative symptoms (deficit syndrome) with blunted affect, emotional and social withdrawal. Amisulpride also controls secondary negative symptoms in productive conditions as well as affective disorders such as depressive mood or retardation.

Associated Conditions
Acute Schizophrenia, Chronic Schizophrenia, Negative Symptoms, Post Operative Nausea and Vomiting (PONV)

Study of APD421 as PONV Treatment (no Prior Prophylaxis)

Phase 3
Completed
Conditions
Postoperative Nausea and Vomiting
Interventions
Drug: Placebo
First Posted Date
2015-05-20
Last Posted Date
2019-01-22
Lead Sponsor
Acacia Pharma Ltd
Target Recruit Count
568
Registration Number
NCT02449291
Locations
🇺🇸

Ohio State University, Columbus, Ohio, United States

🇺🇸

Jackson Memorial Hospital, Miami, Florida, United States

🇫🇷

CHU de Hautepierre, Strasbourg, France

and more 1 locations

Pharmacovigilance in Gerontopsychiatric Patients

Phase 3
Terminated
Conditions
Dementia
Depression
Schizophrenia
Psychosomatic Disorders
Anxiety Disorders
Interventions
First Posted Date
2015-03-02
Last Posted Date
2018-02-28
Lead Sponsor
Hannover Medical School
Target Recruit Count
407
Registration Number
NCT02374567
Locations
🇩🇪

Bezirkskrankenhaus Augsburg, Augsburg, Germany

🇩🇪

Krankenhaus Hedwigshöhe, Berlin, Germany

🇩🇪

Hannover Medical School, Hannover, Germany

and more 2 locations

Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

Phase 3
Completed
Conditions
PONV
Interventions
Drug: Placebo
First Posted Date
2015-01-13
Last Posted Date
2019-03-20
Lead Sponsor
Acacia Pharma Ltd
Target Recruit Count
1147
Registration Number
NCT02337062
Locations
🇺🇸

Ohio State University, Columbus, Ohio, United States

🇺🇸

Stony Brook Medicine, Stony Brook, New York, United States

🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

and more 22 locations

Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients

First Posted Date
2014-12-04
Last Posted Date
2018-10-11
Lead Sponsor
Technical University of Munich
Target Recruit Count
21
Registration Number
NCT02307396
Locations
🇩🇪

Psychiatrische Klinik und Poliklinik fuer Psychiatrie und Psychotherapie der Technischen Universitaet Muenchen am Klinikum rechts der Isar, Munich, Bavaria, Germany

Association of Amisulpride Response in Schizophrenia With Brain Image

Phase 4
Conditions
Schizophrenia
Schizophreniform Disorder
Interventions
First Posted Date
2014-03-26
Last Posted Date
2014-03-26
Lead Sponsor
CHA University
Target Recruit Count
20
Registration Number
NCT02095938

Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study

First Posted Date
2014-01-31
Last Posted Date
2018-03-08
Lead Sponsor
Central Institute of Mental Health, Mannheim
Target Recruit Count
74
Registration Number
NCT02051387
Locations
🇩🇪

Dept. of Pharmacology, University of Cologne, Cologne, NRW, Germany

🇩🇪

Central Institute of Mental Health, Mannheim, BW, Germany

European Phase III Study of APD421 in PONV

Phase 3
Completed
Conditions
PONV
Interventions
Drug: Placebo
First Posted Date
2013-11-25
Last Posted Date
2019-08-20
Lead Sponsor
Acacia Pharma Ltd
Target Recruit Count
368
Registration Number
NCT01991821
Locations
🇫🇷

CHU de Hautepierre, Strasbourg, France

🇩🇪

University Hospitals of Würzburg, Würzburg, Germany

Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics

Phase 1
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2013-10-30
Last Posted Date
2024-06-26
Lead Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Target Recruit Count
105
Registration Number
NCT01972711
Locations
🇬🇧

University of Manchester, Neuroscience and Psychiatry Unit, Manchester, United Kingdom

🇬🇧

Department of Psychiatry, University of Oxford, Warneford Hospital, Headington, Oxford, United Kingdom

Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia

Phase 4
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2013-02-20
Last Posted Date
2015-01-22
Lead Sponsor
Sanofi
Target Recruit Count
316
Registration Number
NCT01795183
Locations
🇨🇳

Sanofi-Aventis Administrative Office, Beijing, China

An Investigation of Early Life Stress and Depression

Phase 1
Completed
Conditions
Major Depressive Disorder (MDD)
History of Childhood Sexual Abuse (CSA)
Interventions
Drug: Placebo
First Posted Date
2012-10-05
Last Posted Date
2025-05-07
Lead Sponsor
Mclean Hospital
Target Recruit Count
153
Registration Number
NCT01701258
Locations
🇺🇸

McLean Hospital, Belmont, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

© Copyright 2025. All Rights Reserved by MedPath